(260 days)
Not Found
No
The description details a mechanical stereotactic instrument with no mention of computational analysis, algorithms, or learning capabilities.
No.
The device is a navigational guide designed to assist in the placement of an intraventricular catheter, not to directly treat a condition.
No
The V-Guide is a surgical instrument used to assist in the frontal placement of an intraventricular catheter during a ventriculostomy. It provides a localized reference guide and allows for angle adjustment to precisely guide the catheter. It does not perform any diagnostic function; its purpose is to aid in a surgical procedure, not to identify or assess a medical condition.
No
The device description explicitly details physical components like a Base Assembly, Impression Pins (needles), a Pierce Sagittal assembly, and a Pierce Barrel, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information about a person's health.
- V-Guide Function: The V-Guide is a surgical instrument used during a surgical procedure (ventriculostomy) to guide the placement of a catheter inside the body (in vivo). It is a tool for performing a medical procedure, not for analyzing a sample from the body.
The description clearly states its purpose is for "frontal placement of an intraventricular catheter during a ventriculostomy" and that it is a "Neurological Stereotactic Instrument." These functions are entirely related to surgical intervention within the body, not laboratory testing of samples.
N/A
Intended Use / Indications for Use
The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters
Product codes
HAW
Device Description
The V-Guide is a sterile, single use, Neurological Stereotactic Instrument that provides the surgeon with a localized reference guide for performing Ventriculostomies. The device is compatible with 3.3mm ventricular catheters. The device consists of a Base Assembly, three Impression Pins (16 Gauge Stainless Steel needles with aluminum hubs) that act as legs for the Base, a Pierce Sagittal assembly and a Pierce Barrel.
The device allows the user to orient the sagittal plane to 0° and the lateral plane to 0°. This aligns the device to a perpendicular track to the entry point. A standard 3.3mm catheter is then passed through the guide into the brain at the predetermined distance as in a standard Ventriculostomy. If the flow of cerebrospinal fluid is noted and the surgeon is satisfied the position of the catheter, the V-guide can be removed from the catheter by removing the barrel. If the surgeon is not satisfied with the position of the catheter, the catheter is removed and this technique can be repeated with different angles to allow for an objective change in direction of the catheters angle to the cranium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following nonclinical testing was performed in order to evaluate the substantial equivalence of the V-Guide to the predicate device:
- Accuracy Testing at 90° at 90° (Sagittal angle adjustment set at 0 and ● Lateral Angle (Barrel) set at 0) the V-Guide will be accurate to ± 3.0mm with a target depth of 6 cm.
This test verified the accuracy of the device using a bench model with a target at 6 cm depth. The accuracy of the V-Guide was compared to the predicate device (Ghajar Guide) using the same bench model. The results of the tests shows that the V-Guide is comparable to the accuracy of the predicate device.
Key Metrics
Accuracy: ± 3.0mm with a target depth of 6 cm.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three bars above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2015
Arc Surgicals Manufacturing LLC. Craig Pagan Consultant 1135 W Nasa Blvd Ste 500 Melbourne, Florida 32901
Re: K141559
Trade/Device Name: V-guide for Ventriculostomies Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 10, 2014 Received: June 12, 2014
Dear Craig Pagan,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141559
Device Name V-Guide for Ventriculostomies
Indications for Use (Describe)
The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitter's name, address, telephone number, a contact person and date (1) summary was prepared:
ARC Surgicals Manufacturing LLC 3259 Progress Drive Suite 166 Orlando, FL 32826 Tel: 407-203-9590 Contact: Habeel Gazi, Director Email: habeel@arcsurgicals.com June 9, 2014 Date Prepared:
Name(s) of device: (2)
| Proprietary/Trade Name: | V-Guide for Ventriculostomies |
|---|---|
| Common Name: | Neurological stereotaxic instrument |
| Classification Name: | Stereotaxic Instrument |
| Classification Panel: | Neurology |
| Product Code: | HAW |
| Regulatory Class: | II |
| Regulation Number | 21 CFR 882.4560 |
Legally Marked Predicate Device to which the submitter claims substantial (3) equivalence:
Arc Surgical Manufacturing's V-Guide for Ventriculostomies is substantially equivalent to the Sparta Instrument Corporation's Ghajar Intraventricular Catheter Guide – K854475.
(4) Description of device(s):
V-Guide for Ventriculostomies (Reorder # 7000)
The V-Guide is a sterile, single use, Neurological Stereotactic Instrument that provides the surgeon with a localized reference guide for performing Ventriculostomies. The device is compatible with 3.3mm ventricular catheters. The device consists of a Base Assembly, three Impression Pins (16 Gauge Stainless Steel needles with aluminum hubs) that act as legs for the Base, a Pierce Sagittal assembly and a Pierce Barrel.
The device allows the user to orient the sagittal plane to 0° and the lateral plane to 0°. This aligns the device to a perpendicular track to the entry point. A standard 3.3mm catheter is then passed through the guide into the brain at the predetermined distance
4
as in a standard Ventriculostomy. If the flow of cerebrospinal fluid is noted and the surgeon is satisfied the position of the catheter, the V-guide can be removed from the catheter by removing the barrel. If the surgeon is not satisfied with the position of the catheter, the catheter is removed and this technique can be repeated with different angles to allow for an objective change in direction of the catheters angle to the cranium.
Indications for Use: (5)
The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters.
Comparison of Technological Characteristics to Predicate Device: (6)
The V-Guide for Ventriculostomies has the same technological characteristics as the predicate device, the Ghajar Guide (K854475) as described below:
- devices are designed to guide catheters for Ventriculostomies ●
- devices have 3 legs that position the device over the burr hole ●
- devices are designed to place catheters at 90° (perpendicular) to the skull ●
- devices are visually placed over the burr hole
- devices are hand held during insertion of the catheter
- both devices are made of plastic material ●
Differences:
The main difference between the V-Guide and the predicate Ghajar Guide is that the V-Guide allows the user to make objective changes in the direction of the catheters angle to the cranium.
| Product
Information | V-Guide
This submission | Ghajar Intraventricular
Catheter Guide | Similarities and
Differences |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Classification | Class II | Class II | Same |
| Regulation Number | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Product Code | HAW | HAW | Same |
| Indications for Use | The V-Guide is designed
to be used for frontal
placement of an
intraventricular catheter
during a ventriculostomy.
The device is for use with
intraventricular catheters. | The Ghajar Guide is
designed to be used as a
device for anterior
placement of an
intraventricular catheter at
ninety degrees to the skull
surface. | Both devices are
indicated for frontal or
anterior placement of
intraventricular
catheters.
The Ghajar Guide is only
indicated for placement
at 90 degrees to the skull |
Substantial Equivalence Comparison
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| Product
Information | V-Guide
This submission | Ghajar Intraventricular
Catheter Guide | Similarities and
Differences |
|---------------------------|-----------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | surface, whereas the V
Guide allows the
physician make objective
changes in the direction
of the catheters angle to
the skull. |
| Catheter
Compatibility | 3.3mm | 1.30 - 3.25mm | V-Guide is compatible
with one size catheter -
3.3mm OD whereas the
Ghajar Guide is
compatible with catheter
from 1.30 – 3.25mm
OD. |
| Materials | ABS with Stainless Steel
Legs (See note 1) | Plastic | The bodies of both
devices are the same -
plastic. The Legs of the
V Guide are made of
stainless steel rather than
plastic. Comparative
testing shows
comparable
performance. |
| Accuracy | $\pm$ 3mm at 6cm target
depth | Unknown | Same – based on bench
test data the V Guide
was comparable to the
Ghajar guide. |
| Sterilization
Method | Gamma | Ethylene Oxide | Sterilization process is
different, but SAL 10-6 is
the same. |
| Single Use | Yes | Yes | Same |
| Packaging | PETG Tray with Tyvek
lid | PETG Tray with Tyvek lid | Same |
Biocompatibility of the Stainless Steel Legs was established based on the Note 1: Covidien product # 8881200052 Monoject™ Standard Hypodermic Needle, Aluminum Hub, 16 G x 1" (1.651 mm x 2.5 cm) A. The FDA classifies this product is a class II device, which is cleared under 510k K854547.
(7) Performance Data:
The following nonclinical testing was performed in order to evaluate the substantial equivalence of the V-Guide to the predicate device:
- Accuracy Testing at 90° at 90° (Sagittal angle adjustment set at 0 and ● Lateral Angle (Barrel) set at 0) the V-Guide will be accurate to ± 3.0mm with a target depth of 6 cm.
6
This test verified the accuracy of the device using a bench model with a target at 6 cm depth. The accuracy of the V-Guide was compared to the predicate device (Ghajar Guide) using the same bench model. The results of the tests shows that the V-Guide is comparable to the accuracy of the predicate device.
Conclusions: (8)
Based on the non-clinical performance data performed comparing the Arc Surgicals Manufacturing V-Guide to the predicate device, it is concluded that the data supports the safety of the device and the hardware verification demonstrate that the V-Guide device should perform as intended in the specified use conditions. The data demonstrate that the V-Guide device performs comparably to the predicate device that is currently marketed for the same intended use.